Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

January 7, 2003

Briefing Information


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

The CAPRICORN Trial - The Efficacy of Carvedilol in Patients with LVD Following A Recent MI, GlaxoSmithKline (PDF)

Joint Clinical Review, FDA (HTM) (PDF) (Word)

Joint Clinical Review Amended, FDA (HTM) (PDF) (Word)

Statistical Review and Evaluation (amendment of Clinical/Statistical Review of 12/04/02) - Errata, FDA (HTM) (PDF) (Word)